CN104826215B - One-pass molding cluster catheter and its production method - Google Patents
One-pass molding cluster catheter and its production method Download PDFInfo
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- CN104826215B CN104826215B CN201510269689.2A CN201510269689A CN104826215B CN 104826215 B CN104826215 B CN 104826215B CN 201510269689 A CN201510269689 A CN 201510269689A CN 104826215 B CN104826215 B CN 104826215B
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- urethral catheterization
- sacculus
- inner tube
- catheter
- check valve
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Abstract
The invention discloses a kind of one-pass molding cluster catheter and its production method, catheter includes processing the urethral catheterization inner tube assembled again, sacculus casing, drainage interface and check valve respectively, and urethral catheterization inner tube is equipped with the sacculus filling pipe being connected to sacculus waterflood path；Urethral catheterization inner tube, sacculus casing, drainage interface, sacculus filling pipe and check valve assemble to form catheter inside subject.One layer of elastic material is impregnated with to form the urethral catheterization outer tube layer being linked together in the outer surface of catheter inside subject, drainage interface egress and check valve inlet and outlet are exposed to outside urethral catheterization outer tube layer, and the tensile strength of catheter cladding material is less than the tensile strength of urethral catheterization inner tube material.This catheter is easily worked and is molded, in Clinical practice the sacculus of catheter be not easily broken, cavity when easy to leak, catheter are not extracted sacculus reliable retraction and can be not easy to plug, be easy dredging blocking.
Description
Technical field
The present invention relates to the improvement of catheter structure, and in particular to a kind of one-pass molding cluster catheter and its producer
Method belongs to the field of medical instrument technology.
Background technology
Currently, most common latex catheter is invented by American's Ahmedabad thirties in last century, passed the nineties in last century
Enter China, in the Clinical practice of over half a century, production technology and technology are almost without substantive changes and improvements,
Significant discomfort can not be adapted to modern industry automation, intelligentized development trend, production together in the requirement of modern medical service level
Accuracy, the standardization aspect of product index also wait to improve.
It is embodied in：
One, product itself has significant deficiency and hidden danger in terms of safety in utilization.Existing production technology and detection method
It is excessively sensitive to determine that latex catheter necessarily will appear balloon occlusion, sacculus rupture, cavity leakage and urethra in Clinical practice
The case of dye, and the ratio for these cases occur can be increased because of the reduction of production management level.Wherein, in balloon occlusion side
Face, in sacculus in separation layer or interleaving agent, sacculus cavity knockout course caused by damage, sacculus cavity mold and its coagulator
Residue and the foreign substance because managing improperly into cavity are the basic reasons for causing sacculus and its cavity to block, big
In the production of scale, existing production Technology can not completely eliminate the adverse effect of these factors；In terms of sacculus rupture,
Sacculus is partially thin, sacculus material aging, sacculus edge and tube body bondability be existing product the reason of causing sacculus to rupture
Latex material is used completely, the smaller extensional rigidity of cavity in the limitation of outer tube diameter and ball determines that sacculus thickness is limited, and
It is influenced by factors to realize that the stabilization of latex molecule between sacculus edge and tube body links, it is difficult to control, the above feelings occur
Condition is unavoidable；In terms of cavity leakage, knockout course is to the damage for the emulsion layer not being completely dried, check valve and sacculus water filling
The connection type of cavity is the reason of causing cavity to leak, and existing technical process can not solve；In terms of urethra allergy infection,
Mainly by coagulator calcium chloride or calcium nitrate cause, existing product is the closed thick-walled product in one end, large-scale production
In be difficult to ensure that the leaching effect of all products reaches requirement, it is inevitable to cause the case that urethra allergy infects.Also, for
Upper problem can completely monitor the technical indicator of all products currently without a kind of detection method.Therefore, existing urethral catheterization
It is inevitable that the mass defect and hidden danger of pipe, which cause a certain proportion of malpractice,.
Two, Clinical practice condition harshness and the inevitable consequence that existing production technology falls behind are that malpractice takes place frequently.In clinic
In, catheter needs to place even several months a couple of days in human urethra, faces various complex situations, and long period of soaking is being urinated
In liquid, the material of product is required it is high, it is also high to the accuracy requirement of each technic index, especially the water imbibition of tube body,
The tensile strength of urethral catheterization inner tube, the fatigue resistance of sacculus and resilience etc., the material selection of latex catheter and technique
Method obviously falls behind.
Three, latex catheter production technology is complicated, process is various, based on manual operations, causes high expensive, quality difficult
With control.Latex catheter is front and back to undergo 30 multiple working procedures from raw and auxiliary material to shaped article, and most processes need craft
Quantitative management is operated and is difficult to realize, the process control in quality system is difficult to carry out, and performance indicator and product quality are artificially controlled
System, necessarily causes quality to be difficult to control.Since most processes need manual operations, in recent years with the rise of cost of human resources,
Production cost is obviously higher.
Start silicone catheter occur the nineties in last century, its main feature is that using silica gel material, physiological inertia is substantially better than
Latex catheter, cavity is produced with extrusion process in ball, but product is not one-pass molding, and sacculus is by the way of heat seal or adhesion
It is connect with tube body, it is also to be docked with tube body in a manner of heat seal or adhesion to drain interface and check valve interface, and effect is unstable, makes
Valence is higher, and sacculus tensile strength is low, due to not having outer layer covers, open defect easily occurs, quality stability is poor, it is difficult to form master
Miscarriage product.
All catheters being currently known, without remedial measure after the blocking of sacculus cavity, and due to catheter clinic
The harshness of use condition is subtle with logical sacculus cavity, and the possibility for occurring blocking exists always, also, in Clinical practice when water filling
The pressure that hand push forms water is far longer than the pressure that sacculus recycling power when discharging water forms water（Especially time of silicone catheter sacculus
Receive power very little）, the malpractice that causes catheter due to water can not put in sacculus catheter can not to be taken out from urethra.When
So, using syringe from the mode of catheter extracardiac pumping and undesirable cavity is closed because it may form negative pressure in cavity.
All catheters being currently known, the mode that check valve is connect with tube body easily make cavity form inflection point and influence
The intrinsic flow of cavity, tie point easily form leakage.Due to being later stage assembly, product is not one-pass molding, and cost is higher,
Easily enter impurity in cavity, quality is more difficult to control, needs to improve.
In the patent announced, also has and propose to make catheter using composite material, as number of patent application is
" a kind of saccule urinary catheter and preparation method thereof " of CN201410693290 and number of patent application is 201410398261.3 " one
Kind novel sacculus catheter ".But its propose by thermosets and thermoplastic material in such a way that medium is bonded together
And it is undesirable, it is well known that this bonding whether can secured inherently technical barrier, it is this be bonded in it is right in 3 years terms of validity
Product material has much influences, and it is still necessary to investigate.Also, sacculus casing is still remained with the risk that cladding material isolates and falls off, sacculus
It still can not be remedied after blocking, product is unable to one-pass molding, and the easy problem majority of catheter still has, and cost is still inclined
It is high.
Invention content
For deficiencies of the prior art, it is easily worked and is molded the purpose of the present invention is to provide one kind, faces
In bed use the sacculus of catheter be not easily broken, cavity when easy to leak, catheter are not extracted sacculus reliable retraction and can be not easy
It blocks, the one-pass molding cluster catheter of dredging is easy blocking.
Invention also provides the production methods of the catheter.
To achieve the goals above, the technical solution adopted by the present invention is as follows：
One-pass molding cluster catheter, including process respectively assemble again have urethral catheterization drainage channel and sacculus water filling logical
The urethral catheterization inner tube in road, the sacculus casing for being used to form sacculus, the drainage interface for being connect with drainage bag and for into sacculus
The check valve of water filling, urethral catheterization inner tube are equipped with the sacculus filling pipe being connected to sacculus waterflood path；The urethral catheterization inner tube, sacculus
Casing, drainage interface, sacculus filling pipe and check valve assemble to form catheter inside subject；In the outer of catheter inside subject
Surface is impregnated with one layer of elastic material to form the urethral catheterization outer tube layer being linked together, and drains interface egress and check valve inlet and outlet dew
Outside for urethral catheterization outer tube layer, the tensile strength of catheter cladding material is less than the tensile strength of urethral catheterization inner tube material；In urethral catheterization
On the tube wall of pipe front end and urethral catheterization outer tube layer is equipped with the drainage entrance of perforation, and drainage entrance is communicated with urethral catheterization passage.
When specific assembling, the drainage interface front end is connect with urethral catheterization inner tube tail portion, and urethral catheterization inner tube tail portion extends to form institute
Sacculus filling pipe is stated, sacculus filling pipe end is connect with check valve；Sacculus casing is sleeved on urethral catheterization inner tube leading portion.
Preferably, sacculus casing both ends are fixedly connected and are closed with urethral catheterization inner tube by binding I, binding I
In in urethral catheterization outer tube layer.
Similarly, the drainage interface front end is sleeved on urethral catheterization inner tube tail portion and is fixed by binding II by position is set with
Connection and closing, binding II are located in urethral catheterization outer tube layer.
Preferably, the water outlet of check valve collapses to form check valve interface, and check valve interface end cross section is noted with sacculus
Waterpipe end cross-sectional is consistent, and check valve interface end is docked with sacculus filling pipe end, the urethral catheterization outer tube layer closing
Wrap up the docking site outer surface.
Further, the sacculus waterflood path in the urethral catheterization inner tube is positioned opposite two, and two sacculus water fillings are logical
Road is communicated by the interconnection on urethral catheterization inner tubal wall with sacculus internal surface of sleeve pipe respectively, and two sacculus waterflood paths are respectively from urethral catheterization
Inner tube tail portion extends out to form two sacculus filling pipes, and two sacculus filling pipe ends are pierced by and divide from drainage interface side wall
It is not connect with check valve.
The connecting portion and drainage interface and the connecting portion of urethral catheterization inner tube of two sacculus filling pipes and check valve pass through
Common fixation stiffening device connection, fixed stiffening device are wrapped on urethral catheterization outer tube layer to wrap up and tight above-mentioned connecting portion
Gu in urethral catheterization outer tube layer, to prevent connecting portion from falling off.The fixed stiffening device fastens shape by opposite two housing sections
At two housing sections fasten to form two or three fixed bayonets, and one of bayonet is for fixed drainage interface and urethral catheterization
Inner tube tail connector position, another or two bayonets are arranged on the side of previous bayonet, for fixing check valve, unidirectional
Valve chest surface is equipped with annular projection and forms fixed ring, and the bayonet that two housing sections are formed corresponds to fixed ring position and is equipped with card slot,
Card slot, which surrounds, blocks corresponding check valve fixed ring, and unidirectional valve head passes through corresponding bayonet to be stretched out out of fixed stiffening device.
The drainage interface is made of three sections of leading portion casing, middle part taper position and endpiece interface position being linked together,
Middle part taper position taper end size is consistent with leading portion casing, and middle part taper position butt end size is consistent with endpiece interface position, preceding
Section casing is sleeved on urethral catheterization inner tube tail portion, and endpiece interface position is stretched out out of fixed stiffening device, for connecting drainage bag.
The fixed stiffening device is in peach-shaped or heart, and surface is smooth.
It is equipped with the injection parallel with center urethral catheterization drainage channel in urethral catheterization inner tube and rinses cavity and thermometric cavity, injection punching
It washes cavity and thermometric cavity to extend out to form injection flushing pipe and thermometric pipeline from urethral catheterization inner tube tail portion, injection flushing pipe
Corresponding casing is housed with thermometric pipeline end sleeve, casing is solid by binding and injection flushing pipe and thermometric pipe end
It is fixed.
One-pass molding cluster urethral catheterization pipe production method, steps are as follows,
1）First processing has the urethral catheterization inner tube of urethral catheterization drainage channel and sacculus waterflood path, is used to form the ball of sacculus respectively
Cuff pipe, the drainage interface for being connect with drainage bag and for the check valve of the water filling into sacculus；Urethral catheterization inner tube tail portion extends
Go out the sacculus filling pipe being connected to sacculus waterflood path；
2）Then urethral catheterization inner tube, sacculus casing, drainage interface, sacculus filling pipe and check valve are assembled and forms catheter
Inside subject；Wherein drainage interface front end is sleeved on urethral catheterization inner tube tail portion, and sacculus casing is sleeved on urethral catheterization inner tube leading portion, water injection pipe
Road end is connect with check valve；
3）The 2nd）The catheter inside subject outer surface that step assembling is formed impregnates one layer of elastic material and is linked as one to be formed
The urethral catheterization outer tube layer of body, the tensile strength of catheter cladding material are less than the tensile strength of urethral catheterization inner tube material；
4）The drainage entrance communicated finally is processed on the tube wall of urethral catheterization inner tube front end and on urethral catheterization outer tube layer, drainage is made to enter
Mouth is communicated with the urethral catheterization drainage channel in urethral catheterization inner tube.
Further, the 3rd）After step forms urethral catheterization outer tube layer, sacculus filling pipe and check valve connecting portion and
Drainage interface is connect with the connecting portion of urethral catheterization inner tube by common fixation stiffening device, and fixed stiffening device is wrapped in urethral catheterization
To wrap up and be fastened in urethral catheterization outer tube layer by above-mentioned connecting portion on outer tube layer, to prevent connecting portion from falling off.
Compared with prior art, the present invention has the advantages that：
1, the original that urethral catheterization outer tube layer is filled a vacancy with natural emulsion or synthetic latex elastomeric material in impregnating process of setting
Reason so that product whole smooth, good airproof performance strengthen the reliability of each connecting portion of product, and binding position is put down after dipping
It is whole smooth；Urethral catheterization outer tube layer has used natural emulsion or synthetic latex elastomeric material natural shrinking in the drying process simultaneously
Principle carries out nature effectively package and sealing to all binding positions and connecting portion, catheter agent structure is made all to connect
It connects to form whole and one-pass molding, not only simplifies process early period of catheter production, and make at the drying, leaching, surface in later stage
The processes such as reason can be carried out continuously, and reduce the process that the later stage separately assembles check valve, optimize the production of entire catheter
Technique greatly reduces the production cost of catheter.
2, sacculus casing is fixedly connected by binding with urethral catheterization inner tube, makes to form an entirety in sacculus, fundamentally
Solving tradition, spacer falls off and closing or blocks balloon lumen aperture in sacculus by felting agent bonding, after bonding agent failure
Hidden danger.The combined use of sacculus casing and binding simultaneously, has used the principle of seal with elastometic washer, has made sacculus edge and urethral catheterization
Inner tube is most directly with secured connection and sealing by way of simplicity, not only simplifying the production technology of catheter, in scale
So that the quality control of catheter sacculus reliability is become more secure in production, while being also beneficial to urethral catheterization outer tube layer material
Multiple choices not only reduce cost, but also have better quality guarantee.
3, the present invention devises double waterflood paths, subtle, water-swellable in cavity when fundamentally solving Clinical practice
Impurity or cavity in subtle damage cause the risk that cavity blocks, the method for use is：When water in discovery sacculus cannot be from list
When being flowed out to valve, can be used the second waterflood path drain, also can into the first waterflood path water filling and pass through the second waterflood path
Discharge forms reflux and is rinsed to cavity, achievees the purpose that dredge cavity.
4, the present invention had both solved the safe handling and securely at the interface position of catheter complexity using fixed stiffening device
In conjunction with problem, and the outer shape of catheter is made to become simple, reduces packaging storing cost, the clean hygiene in Clinical practice.
5, filling pipe and check valve are directly connected to, and are avoided and are formed inflection point on this tie point, and are reduced primary
Connection, simplifies connection type, fundamentally ensures that catheter cavity is not blocked non-leakage on this tie point and maintained just
Normal flow, while being conducive to the reduction of catheter production cost and the simplification of technique；Another side, the phase fills check valve before manufacture
It is fitted on catheter, avoids impurity in production process and enter sacculus water filling cavity and result in blockage, solve existing product and cause
Most hidden danger of balloon occlusion.
It is blocked in short, the present invention thoroughly solves catheter cavity caused by product structure, production technology and foreign substance
And the problem of water in sacculus cannot be discharged, the ability of sacculus resistance to fracture is improved, asking for logical sacculus cavity leakage is efficiently solved
Topic solves the problems, such as that catheter easily causes the infection of urethra allergy, while simplifying the production technology of catheter, reduces
The production of catheter stores and transports cost.
Description of the drawings
Present invention will be further explained below with reference to the attached drawings and examples.
Fig. 1 is urethral catheterization inner tube longitudinal section structural drawing.
Fig. 2 is urethral catheterization inner tube cross-sectional configuration figure.
Fig. 3 is foley's tube outline drawing.
Fig. 4 is binding outline drawing.
Fig. 5 is drainage interface longitudinal section structural drawing.
Fig. 6 is check valve shape assumption diagram.
Fig. 7 is whole longitudinal section structural drawing of the invention.
Fig. 8 is fixed stiffening device internal structure structural map.
Fig. 9 is the catheter outline drawing that sacculus is heaved.
In figure：1, urethral catheterization inner tube；2, sacculus casing；3, binding；4, interface is drained；5, check valve；6, urethral catheterization outer tube layer；
7, fixed stiffening device；11, the first sacculus waterflood path；12, the second sacculus waterflood path；13, the first sacculus filling pipe；
14, the second sacculus filling pipe；15, urethral catheterization drainage channel；41, leading portion casing；42, middle part taper position；43, endpiece interface portion
Position；51, check valve interface；52, one-way valve water inlet；53, check valve fixed ring；71, urethral catheterization inner tube card slot；72, check valve card
Slot；73, urethral catheterization inner tube outlet；74, interface egress is drained；75, one-way valved outlet.
Specific implementation mode
Referring to Fig. 1-Fig. 9, the catheter of the invention with strap-on structure is can be seen that from figure, including process group again respectively
The urethral catheterization inner tube with urethral catheterization drainage channel and sacculus waterflood path of dress, the sacculus casing for being used to form sacculus, for draw
The drainage interface and the check valve for the water filling into sacculus for flowing bag connection, urethral catheterization inner tube are equipped with and are connected to sacculus waterflood path
Sacculus filling pipe, it is characterised in that：The urethral catheterization inner tube, sacculus casing, drainage interface, sacculus filling pipe and check valve
Assembling forms catheter inside subject；It is impregnated with one layer of elastic material in the outer surface of catheter inside subject and is linked as one to be formed
The urethral catheterization outer tube layer of body, drains interface egress and check valve inlet and outlet are exposed to outside urethral catheterization outer tube layer, catheter cladding material
Tensile strength is less than the tensile strength of urethral catheterization inner tube material；It is equipped with and passes through on the tube wall of urethral catheterization inner tube front end and on urethral catheterization outer tube layer
Logical drainage entrance, drainage entrance are communicated with urethral catheterization passage.
When connection, the drainage interface front end is connect with urethral catheterization inner tube tail portion, and urethral catheterization inner tube tail portion extends to form the ball
Capsule filling pipe, sacculus filling pipe end are connect with check valve；Sacculus casing is sleeved on urethral catheterization inner tube leading portion.
Sacculus casing both ends are fixedly connected and are closed with urethral catheterization inner tube by binding I；Similarly, before draining interface
End cap is fixedly connected and closes mounted in urethral catheterization inner tube tail portion and by binding II by position is set with, binding I and binding II
In urethral catheterization outer tube layer.
It is connect with filling pipe for convenience of check valve, avoids the formation of inflection point, the water outlet of check valve of the present invention collapses to be formed
Check valve interface, check valve interface end cross section is consistent with sacculus filling pipe end cross-sectional, check valve interface end with
Sacculus filling pipe end is docked with bonding way, and the docking site outer surface is wrapped up in the urethral catheterization outer tube layer closing.
For the dredging for avoiding after blocking and blocking, the sacculus waterflood path in urethral catheterization inner tube of the present invention is positioned opposite
Two, two sacculus waterflood paths are communicated by the interconnection on urethral catheterization inner tubal wall with sacculus internal surface of sleeve pipe respectively, two
Sacculus waterflood path extends out to form two sacculus filling pipes from urethral catheterization inner tube tail portion respectively, two sacculus filling pipe ends from
It is pierced by drainage interface side wall and is connect respectively with check valve.
In order to ensure the bonding strength of each connecting portion, interconnecting piece of the present invention in two sacculus filling pipes and check valve
Position and drainage interface are connect with the connecting portion of urethral catheterization inner tube by common fixation stiffening device, fixed stiffening device package
To wrap up and be fastened in urethral catheterization outer tube layer by above-mentioned connecting portion on urethral catheterization outer tube layer, i.e., connected by the machinery that outside is added
Binding structure is to prevent connecting portion from falling off.
Specifically the fixed stiffening device is fastened by opposite two housing sections forms, and two housing sections fasten to form two
A or three fixed bayonets, one of bayonet drain interface and urethral catheterization inner tube tail connector position for fixed, another
Or two bayonets are arranged on the side of previous bayonet, and for fixing check valve, annular projection is equipped on check-valve body surface
Formed fixed ring, two housing sections formed bayonet corresponds to fixed ring position be equipped with card slot, card slot surround block it is corresponding unidirectionally
Valve fixed ring, unidirectional valve head pass through corresponding bayonet to be stretched out out of fixed stiffening device.
The fixed stiffening device is in peach-shaped or heart, and surface is smooth.
For convenience of connection, the drainage interface is by the leading portion casing, middle part taper position and the endpiece interface portion that are linked together
Three sections of position composition, middle part taper position taper end size is consistent with leading portion casing, middle part taper position butt end size and endpiece interface
Position is consistent, and leading portion casing is sleeved on urethral catheterization inner tube tail portion, and endpiece interface position is stretched out out of fixed stiffening device, for connecting
Drainage bag.
Cavity and survey are rinsed it is possible to further be equipped with the injection parallel with center urethral catheterization drainage channel in urethral catheterization inner tube
Warm cavity, cavity is rinsed in injection and thermometric cavity extends out to form injection flushing pipe and temperature tube from urethral catheterization inner tube tail portion
Road, injection flushing pipe and thermometric pipeline end sleeve are equipped with corresponding casing, casing by binding and injection flushing pipe and
Thermometric pipe end is fixed.
The composition and connection relation of catheter of the present invention is described above, for a better understanding of the present invention, below with
Each component and its assembling sequence is described in detail in the form of embodiment.
Embodiment one
Step 1：As shown in figs 1 to 6, catheter main metal fixture is made.Including urethral catheterization inner tube 1, sacculus casing 2, binding
Object 3, drainage interface 4, check valve 5.
Urethral catheterization inner tube 1 uses extrusion process, and, bending strength lower common plastics material preferable using extensional rigidity be
Can, it actually uses common medical pipeline plastic material extrusion molding and forms, outer diameter is determined according to catheter specifications and models, pipe thickness
For 0.3-4mm, length is 200-400 mm, inside sets two or two or more channels, includes at least a urethral catheterization drainage channel
15 and the first sacculus waterflood path 11, can also include the second sacculus waterflood path 12, injection irrigation channel, thermometric channel etc.；
The urethral catheterization drainage channel 15, depending on requirement of the internal diameter according to catheter different size model to flow；The sacculus note
Aquaporin, internal diameter are 0.5-1 mm；The use of second sacculus waterflood path 12 and its second sacculus filling pipe 14, from basic
On subtle damage causes the wind that cavity blocks in subtle, water-swellable impurity or cavity in cavity when solving Clinical practice
Danger, the method for use are：When finding that water cannot be flowed out from check valve 5 in sacculus, 12 row of the second sacculus waterflood path can be used
Water, also can into the first sacculus waterflood path 11 water filling and by the second sacculus waterflood path 12 be discharged, formed reflux to cavity
It is rinsed, achievees the purpose that dredge cavity.The urethral catheterization inner tube 1, has relative to catheter lumens made of natural emulsion
There are apparent superior extensional rigidity and a torque, flexural strength is then relatively.
As shown in Figure 1, after formed pipe is made, one end need to be cut, form two sacculus filling pipes 13,14.
Sacculus casing 2 uses impregnation technology, using elastic preferable natural emulsion material, 2 internal-and external diameter of sacculus casing according to
Catheter specifications and models determine that thickness in monolayer 0.1-1mm, length is depending on sacculus capacity.The sacculus casing 2 makes
With making the tensile strength of catheter sacculus significantly improve, the ability of sacculus resistance to fracture made to have the guarantee in material.
The drainage interface 4 is made using the larger elastic material of tensile strength by impregnation technology, including day
Right latex, synthetic latex, silica gel, plastics.Interface internal diameter be 3-8 mm, wall thickness 2-4mm, length 50-70mm, from interface to
Tube body transition has a pyramidal structure, pyramidal structure front end to set the casing of one section of 10-30mm, internal diameter and the urethral catheterization inner tube 1 of casing
Outer diameter matches, for the connection with urethral catheterization inner tube 1；Therefore drainage interface 4 includes leading portion casing 41,42 and of middle part taper position
43 3 sections of endpiece interface position, endpiece interface position 43 is for connecting drainage bag.The use of the drainage interface 4, makes urethral catheterization
Pipe becomes easy and securely with the connection of drainage pack adapter, hence it is evident that better than the simple catheter using silica gel and plastic material at present
Drain the connection type of interface.
Binding 3 uses the larger material of tensile strength, including fiber, plastics, metal；Binding 3 can be coil shape
, it can also be sleeve, can directly bundle, can also be bundled by heat-shrinkage material, be used in the two of sacculus casing 2
The side repeatedly bundled may be selected to ensure the secured of binding site in the connecting portion of end and drainage interface 4 and urethral catheterization inner tube 1
Formula.The pulling force that circle body can bear 5-10N is not broken.
Check valve 5 is to be inserted into injection tube to inject water, extracts the internal existing accessory closed water and do not flow out after injection tube,
Increase one or two interface being connect with cavity extension on this basis.It is formed, is inside had stainless using hard plastic injection molding
Steel spring, tail end water outlet shrink to form check valve interface 51, have an annular projection for fixing to form list in middle housing
To valve fixed ring 53, front end is one-way valve water inlet 52.
Step 2：As shown in fig. 7, installation diagram 1- catheter main metal fixtures shown in fig. 6.First by one section of 200-400mm
1 one end of urethral catheterization inner tube closed with the mode for being inserted into plug, close to the place blind end 10-60mm, lead to respectively in two sacculus water fillings
Open one or more apertures in road 11,12（Interconnection）, the two cavities is made to be communicated with outside.Sacculus casing 2 is sleeved on urethral catheterization
Outside inner tube 1 and fully wrapped around all apertures, 2 both ends binding 3 of sacculus casing bundle tightly.The leading portion casing of interface 4 will be drained
41 are sleeved on 1 unclosed one end of urethral catheterization inner tube（Tail portion）And bundled tightly using binding 3, and two sacculus filling pipes 13,14 is made to wear
The glue-line for crossing drainage interface 4 reaches outside tube body, because drainage interface 4 is elastic material, perforated edge natural enclosing.Two sacculus are noted
The end of waterpipe is directly connected to and is closed in a manner of bonding with check valve interface 51, and two sacculus filling pipes access a list
When to valve 5, three-way connection can be used.Catheter inside subject is formed after above-mentioned component assembling, catheter inside subject is except drainage
All it is completely enclosed outside interface and check valve water filling port, when the later stage being made to impregnate outer layer, latex solution will not enter in catheter
Portion.
Step 3：As shown in fig. 7, impregnating urethral catheterization outer tube layer 6 outside catheter inside subject.First by a linear material mould
Tool is inserted into from drainage interface in catheter urethral catheterization drainage channel 15, drains interface 4 and check valve 5 is fixed, make catheter main body
With certain and fixed position, secondly catheter is impregnated in coagulator, in the glue that gel content is 30-50% after appropriate drying
1-30min is impregnated in lotion, the position of latex solution dipping should be more than total interface and close the position of mouth, make total interface and envelope
It is silent all by catheter outer layer covers and to close, then through leaching, drying, post-processing, remove mold, catheter main body
Type.6 thickness of urethral catheterization outer tube layer is 0.1-1.5 mm, because thickness is smaller, belongs to thin-gage goods, later stage leaching, drying are easy；It is described
Urethral catheterization outer tube layer 6 in silicon materials, anti-biotic material or superslide material can be added but sacculus safety is unaffected, optimization is led
The performance of urinary catheter provides great convenience.
The use of urethral catheterization outer tube layer 6 is mended with natural emulsion or synthetic latex elastomeric material in impregnating process of setting
Scarce principle makes binding position flat smooth after dipping；The use of the urethral catheterization outer tube layer 6, used natural emulsion or
The principle of synthetic latex elastomeric material natural shrinking in the drying process carries out nature to all binding positions and connecting portion
Effective package and sealing, making catheter agent structure, all connection forms whole and one-pass molding, not only simplifies catheter life
Process early period of production, but the processes such as drying, leaching, surface treatment for enabling the later stage are carried out continuously production, and reduce the later stage
The process for separately assembling check valve, optimizes the production technology of entire catheter, greatly reduces the production cost of catheter.
Step 4：As shown in figure 8, fixed stiffening device 7 is assembled in catheter main body according to the position marked.Gu
Determine stiffening device 7 to be surrounded and formed by protecgulum and rear cover two parts, is combined to form card slot and outlet（Bayonet）, wherein urethral catheterization
Pipe urethral catheterization inner tube is stretched out from the urethral catheterization inner tube outlet 73 of fixed stiffening device 7, and drainage interface 4 is stretched out from drainage interface egress 74,
Check valve 5 is stretched out from one-way valved outlet 75.Urethral catheterization inner tube card slot 71 on fixed stiffening device wraps up urethral catheterization inner tube and is connect with drainage
The connecting portion of mouth 4, makes urethral catheterization inner tube fix, and check valve card slot 72 wraps up check valve 5, and check valve fixed ring 53 is embedded in check valve
In gap between card slot 72 and one-way valved outlet 75, check valve 5 is made to be fixedly secured.It can be tight with screw between protecgulum and rear cover
Gu keeping fixed stiffening device secured and solid.Fixed 7 contour structures of stiffening device are a smooth entirety.It is fixed to reinforce dress
7 are set using common plastics or metal injection molded is formed, it is possible to provide the rigging position of the accessories such as antipriming.
The use of fixed stiffening device 7, had both solved safe handling and the firm connection at the interface position of catheter complexity
Problem, and the outer shape of catheter is made to become simple, packaging storing cost is reduced, the clean hygiene in Clinical practice may be used also
Chance is provided for the appearance design of catheter, can effectively promote image product.
Step 5：As shown in figure 9, in catheter at blind end 3-20mm（But it is no more than sacculus marginal position）It liquidates
Go out the drainage entrance of two circle hole shape cost products, drains pass-through entry urethral catheterization outer tube layer and urethral catheterization inner tubal wall, make drainage entrance
It is communicated with the urethral catheterization passage in urethral catheterization inner tube.
Embodiment two
As the supplement of embodiment one cavity of another sacculus can be added if you need to use double sacculus in urethral catheterization inner tube 1
And cavity extension, and add a check valve, sacculus casing 2 bundled using binding 3, check valve directly with sacculus filling pipe
Connection, it is identical as single saccule technique.
Embodiment three
As the supplement of embodiment one, cavity or thermometric cavity are rinsed if you need to add injection, can be pressed in urethral catheterization inner tube 1
It is required that internal diameter add one or two cavity, still by the way of extension, cavity or thermometric are rinsed in connection injection for cavity end
Interface needed for cavity, fixed stiffening device 7 add corresponding outlet.
Example IV
In above-described embodiment one, second sacculus waterflood path 12 and corresponding sacculus filling pipe 14 can not also connect
Enter in check valve 5, and individually closes as spare cavity.
Embodiment five
In above-described embodiment one, two sacculus filling pipes 13,14 are changed in addition connect using connecting tube, although more
One tie point, increases the risk of leakage, but remains to make catheter normal use, can also be used as the embodiment of the present invention.
The above embodiment of the present invention is only example to illustrate the invention, and is not to the present invention
The restriction of embodiment.For those of ordinary skill in the art, it can also be made on the basis of the above description
His various forms of variations and variation.Here all embodiments can not be exhaustive.Every technology for belonging to the present invention
Row of the scheme changes and variations that derived from still in protection scope of the present invention.
Claims (7)
1. one-pass molding cluster catheter, including process respectively assemble again there is urethral catheterization drainage channel and sacculus waterflood path
Urethral catheterization inner tube, be used to form the sacculus casing of sacculus, the drainage interface for being connect with drainage bag and for being noted into sacculus
The check valve of water, urethral catheterization inner tube are equipped with the sacculus filling pipe being connected to sacculus waterflood path, it is characterised in that：The urethral catheterization
Inner tube, sacculus casing, drainage interface, sacculus filling pipe and check valve assemble to form catheter inside subject；In catheter
The outer surface of portion's main body is impregnated with one layer of elastic material to form the urethral catheterization outer tube layer being linked together, drainage interface egress and unidirectional
Valve inlet and outlet are exposed to outside urethral catheterization outer tube layer, and the tensile strength of catheter cladding material is strong less than the stretching of urethral catheterization inner tube material
Degree；It is equipped with the drainage entrance of perforation on the tube wall of urethral catheterization inner tube front end and on urethral catheterization outer tube layer, drains entrance and urethral catheterization passage
It communicates；
Sacculus waterflood path in the urethral catheterization inner tube is positioned opposite two, and two sacculus waterflood paths pass through urethral catheterization respectively
Interconnection on inner tubal wall is communicated with sacculus internal surface of sleeve pipe, and two sacculus waterflood paths extend from urethral catheterization inner tube tail portion respectively
Form two sacculus filling pipes, two sacculus filling pipe ends are pierced by from drainage interface side wall and connect respectively with check valve
It connects；
The connecting portion and drainage interface and the connecting portion of urethral catheterization inner tube of two sacculus filling pipes and check valve pass through common
The connection of fixation stiffening device, fixed stiffening device is wrapped on urethral catheterization outer tube layer to wrap up and be fastened on above-mentioned connecting portion
In urethral catheterization outer tube layer, to prevent connecting portion from falling off；The fixed stiffening device surface is smooth；
The fixed stiffening device is fastened by opposite two housing sections to be formed, and two housing sections fasten that form two or three solid
Fixed bayonet, one of bayonet is for fixed drainage interface and urethral catheterization inner tube tail connector position, another or two bayonets
It is arranged on the side of previous bayonet, for fixing check valve, is equipped with annular projection on check-valve body surface and forms fixed ring,
The bayonet that two housing sections are formed corresponds to fixed ring position and is equipped with card slot, and card slot, which surrounds, blocks corresponding check valve fixed ring, single
Corresponding bayonet is passed through to be stretched out out of fixed stiffening device to valve head.
2. one-pass molding cluster catheter according to claim 1, it is characterised in that：The drainage interface front end with lead
The connection of inner tube tail portion is urinated, urethral catheterization inner tube tail portion extends to form the sacculus filling pipe, sacculus filling pipe end and check valve
Connection；Sacculus casing is sleeved on urethral catheterization inner tube leading portion.
3. one-pass molding cluster catheter according to claim 2, it is characterised in that：Sacculus casing both ends pass through
Binding I is fixedly connected and closes with urethral catheterization inner tube, and binding I is located in urethral catheterization outer tube layer.
4. one-pass molding cluster catheter according to claim 2, it is characterised in that：The drainage interface front end suit
It is fixedly connected position is set with and closes in urethral catheterization inner tube tail portion and by binding II, binding II is located at urethral catheterization outer tube layer
It is interior.
5. one-pass molding cluster catheter according to claim 1 or 2, it is characterised in that：The water outlet of check valve is received
Hold together to be formed check valve interface, check valve interface end cross section is consistent with sacculus filling pipe end cross-sectional, check valve interface
End is docked with sacculus filling pipe end, the urethral catheterization outer tube layer closing package docking site outer surface.
6. one-pass molding cluster urethral catheterization pipe production method described in claim 1, it is characterised in that：Steps are as follows,
1）First processing has the urethral catheterization inner tube of urethral catheterization drainage channel and sacculus waterflood path, is used to form the sacculus set of sacculus respectively
Pipe, the drainage interface for being connect with drainage bag and for the check valve of the water filling into sacculus；Urethral catheterization inner tube tail portion extend with
The sacculus filling pipe of sacculus waterflood path connection；
2）Then urethral catheterization inner tube, sacculus casing, drainage interface, sacculus filling pipe and check valve are assembled and is formed inside catheter
Main body；Wherein drainage interface front end is sleeved on urethral catheterization inner tube tail portion, and sacculus casing is sleeved on urethral catheterization inner tube leading portion, filling pipe end
Portion is connect with check valve；
3）The 2nd）The catheter inside subject outer surface that step assembling is formed impregnates one layer of elastic material and is linked together with being formed
Urethral catheterization outer tube layer, the tensile strength of catheter cladding material are less than the tensile strength of urethral catheterization inner tube material；
4）Finally process the drainage entrance communicated on the tube wall of urethral catheterization inner tube front end and on urethral catheterization outer tube layer, make drainage entrance with
Urethral catheterization drainage channel in urethral catheterization inner tube communicates.
7. one-pass molding cluster urethral catheterization pipe production method according to claim 6, it is characterised in that：3rd）Step is formed and is led
It is logical in the connecting portion and drainage interface and the connecting portion of urethral catheterization inner tube of sacculus filling pipe and check valve after urinary catheter outer layer
Common fixation stiffening device connection is crossed, fixed stiffening device is wrapped on urethral catheterization outer tube layer to wrap up simultaneously above-mentioned connecting portion
It is fastened in urethral catheterization outer tube layer, to prevent connecting portion from falling off.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510269689.2A CN104826215B (en) | 2015-05-25 | 2015-05-25 | One-pass molding cluster catheter and its production method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510269689.2A CN104826215B (en) | 2015-05-25 | 2015-05-25 | One-pass molding cluster catheter and its production method |
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| CN104826215A CN104826215A (en) | 2015-08-12 |
| CN104826215B true CN104826215B (en) | 2018-09-04 |
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| CN201510269689.2A Expired - Fee Related CN104826215B (en) | 2015-05-25 | 2015-05-25 | One-pass molding cluster catheter and its production method |
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| US4793351A (en) * | 1987-06-15 | 1988-12-27 | Mansfield Scientific, Inc. | Multi-lumen balloon catheter |
| CN1628601A (en) * | 2003-12-17 | 2005-06-22 | 富士能株式会社 | Method for fixing one of balloon and tubular member, and medical equipment |
| CN104127951A (en) * | 2014-08-13 | 2014-11-05 | 广州维力医疗器械股份有限公司 | Novel balloon urethral catheter |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3460540A (en) * | 1966-04-18 | 1969-08-12 | Davol Inc | Plastic catheter with rubber balloon |
| GB8517091D0 (en) * | 1985-07-05 | 1985-08-14 | Franklin Medical Ltd | Balloon catheters |
| GB9014187D0 (en) * | 1990-06-26 | 1990-08-15 | Brown John J | Self retaining urinary catheter |
| US7766899B2 (en) * | 2003-09-17 | 2010-08-03 | Prostalund Operations Ab | Partial-length, indwelling prostatic catheter using coiled inflation tube as an anchor and methods of draining urine and flushing clots |
| US20050177104A1 (en) * | 2004-01-22 | 2005-08-11 | Rochester Medical Corporation | Cuff resistant foley catheter |
| CN201668849U (en) * | 2010-05-17 | 2010-12-15 | 高峰 | Urethra overall length spiral flushing and discharging separating type catheter |
| US8939962B2 (en) * | 2013-04-17 | 2015-01-27 | Ramyar Azar | System and method for urinary catheterization |
| CN104368078B (en) * | 2014-11-26 | 2018-02-27 | 广州维力医疗器械股份有限公司 | A kind of saccule urinary catheter and preparation method thereof |
| CN204428604U (en) * | 2015-01-21 | 2015-07-01 | 中国人民解放军总医院 | Disposable multiplex roles can extenal fixation urinary catheter |
| CN204655759U (en) * | 2015-05-25 | 2015-09-23 | 陈劲松 | One-shot forming cluster catheter |
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2015
- 2015-05-25 CN CN201510269689.2A patent/CN104826215B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4793351A (en) * | 1987-06-15 | 1988-12-27 | Mansfield Scientific, Inc. | Multi-lumen balloon catheter |
| CN1628601A (en) * | 2003-12-17 | 2005-06-22 | 富士能株式会社 | Method for fixing one of balloon and tubular member, and medical equipment |
| CN104127951A (en) * | 2014-08-13 | 2014-11-05 | 广州维力医疗器械股份有限公司 | Novel balloon urethral catheter |
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|---|---|
| CN104826215A (en) | 2015-08-12 |
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